Task, could you just go in a Q&A or?
Okay, sure.
Oh, yeah. Is this being broadcast?
Yeah. Good morning, everyone. My name is Balaji Prasad. I'm the Senior Analyst for the Specialty Pharmaceuticals sector. Continuing with the Spec Pharma track of our Barclays Healthcare Conference, I'm delighted to have Chirag Patel, the Chairman and CEO of Amneal Pharmaceuticals, with us. Amneal, over the last couple of years, has seen an exceptional turnaround, a name that we've been very bullish on on multiple sides, be it on the complex generics or biosimilars or specialty pharmaceutical side. The company continues to deliver, and we are glad to have Chirag here with us and dig into some of these dynamics. Chirag, thank you so much for joining us.
Thank you, Balaji, for having me.
Yeah.
The beautiful weather in Miami.
Indeed. I hope you got some time out there. Starting with the business, you recently reported Q4 earnings. Maybe take us through some of the key highlights there and also use that as a segue to discuss the outlook for 2025, as you said, Chirag.
Yeah, Balaji. Amneal, we delivered another great growth year in 2024, continuing the momentum in 2025 as well. All segments of our business are performing really well. If I walk you through each segment, how well it did in 2024 and why we are so bullish in 2025, 2026, 2027, basically, we have mapped out next seven years or so growth plan already. The areas we're excited about are all of them. Let's start with, we call it affordable medicine segment, which we define as a traditional generics business, biosimilars, and hospital injectable business, including bags. The affordable medicine segment has a huge growth potential. The LOEs are coming. There's a void in biosimilars. If you get it right and execution, affordable medicines for us and our key competitors will grow in a significant manner over the next five to seven years.
That segment you saw the growth in 2024, we're so excited it will keep growing in 2025 and beyond. We have an excellent pipeline. We launch 20-30 products every year in affordable segment categories. We actually, our base business continues to do well as well. We're not seeing as much of a price erosion in traditional generics as we saw a few years ago. Everything is pointing towards growth for the entire segment. It's a big segment. It's 92% of prescriptions in the United States. Biosimilars has a potential of delivering $100 billion a year savings for American patients and healthcare systems in 2032. Government is completely supporting the FDA, obviously, to ease the development of biosimilars. The $6 billion biosimilar category could get to $30 billion-$35 billion in the next five to seven years. Huge growth potential there.
The second segment, specialty, we're extremely excited and pleased to report that Crexont is outperforming our own expectations. The patient testimonials are just superb. It makes us feel so good. I mean, our purpose as a company is to make healthy possible. The patient testimonials, such as the patient was not walking for five, six years properly, now able to walk. The MDS specialist by himself has Parkinson's. He just texted us saying he's moving much better than Rytary.
Okay.
We believe that the market is so wide. Later on, we can cover more on Crexont, but specialty business is doing well as well. Our third segment, distribution, outperformed our expectation as well. That is government value-added distribution, which requires made in the United States, TAA-compliant products. Amneal, as one of the largest US manufacturers, we have an advantage to do business with VA and DOD. It was great here. Starting out 2025, great as well.
Fantastic. Chirag, let's discuss, start with Crexont. I mean, launched a couple of months ago. Clearly, could see that there's a lot of excitement around it. I am on the call too. How is the clinical protocol evolving at the clinic side in terms of changing from existing drugs, Parkinson's drugs, towards Crexont? Also, maybe just remind us, where are you with the payer coverage so far?
Yeah, so we're, as I said, testimonials are awesome. The uptake is awesome. We are over 1,000 prescriptions per week, and it's growing every week. We are touching every avenue. We're first time has opened up the market to general neurologist, not only movement disorder specialist. We're going to long-term care. We just got coverage for VA, DOD. That's almost 7%-10% of the market. We are running Phase IV to basically put it in context what we are already hearing from the patient so that we'll have the results in fourth quarter this year. Payer coverage, excellent. So far, we are in a very positive manner moving forward, and we'll be announcing as soon as we line up with the largest insurance companies. They're seeing the benefits for the product for the patient. We're very pleased to how it's moving.
Got it.
We should exit more than 50% coverage this year.
Exit more than 50% towards the end of the year.
Yep.
Okay, great. Look forward to that. In terms of the launch and the differences between, let's say, going back to Rytary when it launched versus this, what are the incremental things which are driving Crexont?
Yeah, so we, it's 2016.
Yeah.
Rytary launch was slow in uptake. Amneal was not involved. Amneal acquired the company in 2018, and we grew the business then. If I look at the data, it took almost two years for Rytary to get to 1% or 2% market share. This is happening in three, four months. It is a very large market, and Impax never penetrated or went after a bigger market. Conversion was an issue from IR to because of the complexity of dosing. They did not go after the bigger market, and they were not equipped to do it as well. They did not have the team. Now, with experience since 2018, we grew Rytary from $80 million product to $210 million product, grew from 2% to 6%. We learned a lot. We have a relationship that is great. Our product is great.
We see now, and we have the label for naïve patients. We are pushing with general neuro, we will need some more data for naïve patients to convince them. There is a total of 670,000 Parkinson's patients. Rytary was used by 40,000, approximately. We believe we can get up to now more than 20% of the market share, if not more. I mean, if you ask our CMO, who would be biased, saying all 670,000 patients should be on Crexont, there is no need for IR. That is a pretty old technology, a lot of absorption issues on and off time. It is not doing any good for patients. Why should they be on IR?
Got it.
Huge market.
That's a pretty interesting, pretty exciting number out there, 20% market share, which is substantially above Rytary.
Yeah.
Look forward to traction on that. Maybe taking a step above and thinking about the overall Parkinson's franchise. I mean, Rytary will be seeing an LOE, and then you have Inbrija that you picked up recently, and of course, Crexont. Overall, how should we think about the Parkinson's franchise? As we think about this commercial strategy, is there anything else which comes next or incremental?
Yeah, it'd be flat this year compared to last year, and then grows from 2026 and tremendous growth from 2027.
Yeah, okay. I think one of the things that we've been discussing with KOLs last year was if there is going to be cannibalization of Rytary by Crexont, but KOLs were not convinced that would be the case. Is that something that you're seeing too?
Now we're getting more IR patients on Crexont, and Rytary patients are also moving to Crexont. So we're seeing both.
Got it. Shifting away from the Parkinson's side to the DHE Auto-Injector, seem to be expecting an approval in 2Q and a potential launch in 2H 2025. Help us understand a bit more on the product and the opportunity as you see it.
There's another niche product, right? Our specialty segment is defined by niche product, which big pharma typically, obviously, do not pursue. They are somewhere between $100 million-$500 million. Sometimes we may hit a really good product like Crexont, which could do even more. The DHE auto injector is for, it's again the gold standard for the.
Migraine?
The cluster headache patients, as well as severe migraine patients. Right now, they would have to go to clinic. It takes two, three hours to get there being administered. Tremendous pain until then. We have come up with an auto injector at home they can inject and get immediate relief in the next 20, 30, 40 minutes rather than going for three, four hours. Tremendous need. The KOLs are very excited about this. We are looking for an exciting launch in the second half of this year.
Great. Maybe last question around the subject. Help us understand the infrastructure that you have in place. I know that with Crexont, you're now also reaching out to general neurologists. With DHE, would Amneal sales force, are you geared enough to?
Oh, we have a great team of 200 people, including market access, sales team. We would probably add 10-20 specialists who would call into these big migraine management centers.
Understood. Shifting towards the biosimilar side, again, that's one place I've been really impressed with the pace that Amneal ramped up, starting from just talking about in 2020 to having three products by the end of 2022 and now like a $200 million revenue size there. What's next on the biosimilar pipeline side of things? I know it's going to be dependent on partner discussions, but what's happening?
Yeah, it's a very exciting area for us, and it's in our wheelhouse. This is what we do really well, produce complex products at a large scale. In the beginning, we had the commercial model. We did not want to invest a whole lot of money until the market stabilizes. The FDA guidance is more amicable, more easier than what used to be, which is all happening at the same time, trifecta. I'm probably the only one calling this a golden era of biosimilars from now to next five, seven years. You will see people are always hung up on Humira. There are 120 products. That was just a couple of years that brand company protected its franchise. Now you can see the Humira market share with the biosimilar players. Competition is lower compared to before. The brand companies are pretty much out except Amgen.
The competition's main competition is Sandoz, Celltrion, Teva, Alvotech, mAbxience, Kabi. Amneal will have to integrate with R&D and manufacturing unit somewhere along the time, which we've been very public about it that we would look to do that this year. That will give us additional pipeline. We're launching three products by 2027. Xolair is a big opportunity for us. We could be the second in the market after Celltrion. We have Xgeva, Prolia, and OBI for our current Neulasta franchise. After that, we would have many biosimilars if we are successful integrating the business. We'll have full control from R&D, manufacturing, the sales and marketing, commercial functions in the United States. Our strategy is to partner in Europe with European champion, partner in South America with whoever specializes there. Middle East, the demand for these products is amazing.
The excess it creates, the volume it grows because now it's affordable and available. And how many patients it helps. I mean, think about it. These are great products, never reached so many patients globally. So it's a very exciting business, and we're fully committed to making it really big. And just like our on a small molecule, we are in top five. We will do the same for biosimilars.
Fantastic, Chirag. Maybe do you want to comment very quickly around your expectations around Xolair and Prolia?
They're going to be great products. Xolair is going to be very big. Prolia, Xgeva are more competitive. Xolair, if we are second, then Teva is publicly saying they'll be there in 2028. Three players you tend to do really well in biosimilars.
Got it. Last one on the biosimilar side is more around the partnerships and the deals. You commented that you'll be looking to add a couple of deals every year. You rightly said that there are many, many biologics which are expiring and we have not seen that yet in the U.S. Tell us about the environment for these deals and what kind of assets you're looking at.
We usually have two kinds of deals we look for. We have, first of all, organically really great pipelines. We are not in a position where we have to do the deal except for integrating biosimilar business. We look at specialty assets. We are quietly building our branded oncology business against specialty assets. We are launching 505(b)(2)s. You will see us doing more in onco. Some of the biosimilars deal will continue to happen. Those are from the deal standpoints.
Got it. Shifting towards the generic side of things or the complex generic side of things, I think you'll be very happy to notice that analysts don't ask you about generic pricing erosion anymore. That used to be the only question being asked for the last couple of years. Your portfolio clearly, as your focus on complex generics, has expanded significantly. Could you call upon the pipeline and highlight the key ones that we ought to be looking for on the portfolio side of things for 2025 and 2026?
Yeah, it's in our presentation. There are many products, 20-30 products. We already launched three good ones at the beginning of the year, everolimus, mesalamine, and picked up the market share on levothyroxine. We're picking up more market share as some of our competitors may run into FDA issues while Amneal works very hard to maintain its top rating and quality. We benefit from those areas as well. It is a very healthy market, lots of LOEs on the affordable medicine segment, essential business for the country and the world. We're very excited about the growth.
Great. On the injectables side of things, you again called it out within your affordable medicine segment. Help us understand the current capacity that you have and the need for incremental capacity or how well equipped the company is towards this.
Yes. We built out capacity for about 60 million-70 million units. Our approach is very targeted, 505(b)(2)s, more complex injectables, microspheres, and long-acting depot, which we're able to peptide. We just got our first GLP-1 approved, the old one. With that, we are pretty right size in capacity for the next four, five years. We're good. Where we are building capacity is on our newly announced partnership with Metsera on a peptide fronts.
I want to dig into Metsera. I'm glad that you mentioned it. Help us understand, announced it a few months ago. Where are you currently in your discussions for various things, setting up capacity, and then how do you identify assets? When could we expect to see the outcomes of this partnership? Is it a three-year thing or a five-year thing?
Great. Very excited. I think Clive and us will take the credit to put up such a unique deal where Amneal has huge capacity, capabilities, the CMC expertise, 800 scientists. We have unleashed all that capability for Metsera to get their projects, help them move forward in CMCs and formulation enhancement for the oral solids because we have worked on 300 of them. We know what to do and how to improve and lots of science. The gratitude from the Metsera team is amazing. It is unique. It is not a CMO, CDMO. It is more of a unique partnership at scale that immediately gave Metsera scale. You saw the announcement, Corden followed up with what we did with Viking a few days ago. We love to be pioneers in these areas, and we're expanding that partnership. Two plans will be ready.
Some of the existing plants we are using for their Phase III , as well as their initial launches, where we expect the sites to be up and running by end of 2027. We also have marketing rights for their products in 20 emerging countries, including India. India market is about 50 million patients that could be on this GLP-1 if price is right. You cannot have, obviously, the U.S. prices there. Tremendous growth. We will start seeing it from 2028, the revenue contribution going more on 2029, 2030. Our first preference on GLP-1 is to work with Metsera. We are their preferred suppliers for U.S. and Europe. 70% products they would have to buy from us. They are putting $100 million in CapEx. We are putting about $100 million. We expect the government incentives about another $80 million-$100 million.
That's good for 100 million cartridge capacity. Oral solid, we already have the capacity. Do not need to build new. Four to seven tons of peptide manufacturing, which we're using novel method of liquid phase chemistry as well as solid phase. Have more yield like Lilly got it for Mounjaro. Because solid phase alone would be too tough, especially when you have the oral solids, which would expand the market really well. It's absolutely. I were just quickly finishing that. Second priority in that new infrastructure is where also we'll approach Novo, Lilly, Roche to do some contract manufacturing for them, either for the emerging markets or even for U.S., Europe. These sites are for global use. The third is we'll be ahead in generics launches as well because we'll have infrastructure to launch GX products.
When you say that, you mean generic GLPs?
Yeah.
Yes. Right. Chirag, look forward to that. I think that could be truly transformative for the company.
It is. It is. If you look at Amneal, the specialty where it's headed, biosimilar where it's headed, the complex GX or distribution business, and top of that you add peptide. I haven't even talked about international growth. It's all huge growth potential for Amneal from now to next five, ten years.
Fantastic. Let's speak about that. We still have a couple of minutes left.
Sure.
Let's speak about the international part of the business. It is a very unique model where a U.S.-based firm starts looking at the specialty generic side, looks at the international market, which is not frequent.
Yeah. We have obviously we're a U.S. company. All our products are approved by US FDA, number one in quality. It has a unique demand in Middle East, anywhere we go in the world. Instead of setting up our own distribution centers, which would be too much and will not be that much value added, we're partnering with key partners. We already have almost 40 partnerships with Middle East, Southeast Asia, Canada, Europe. Our products will go through our partners who are set to distribute in these countries. We picked about 50 small molecule assets, which are already approved in the United States. We signed up our Crexont also is going international. First time, the International Parkinson's Patient, which is more than 10 million, would get access to a most advanced drug formulation than the IR. You see the need is same.
We'll launch in Europe, Canada. In India, we decided two years ago to set our own sales and marketing since we operate many facilities in India, familiar with India. India is a growing market. India is going to almost triple in their entire economy, but also in pharmaceuticals. It's pretty small compared to the U.S. It's a $27 billion total market. It will go to $75 billion-$100 billion over the next 10 years. We would like to establish our footprint there. We have started just doing that. It's small, $15 million-$20 million business, but it will grow tremendously over the next several years. It's branded. It's not generics. It's a branded unmet need we're bringing in India and certain specialty assets.
Got it. We're out of time, but I want to ask one final question. I think it's pretty important, especially around operating margins. Last couple of years, market focus, investor focus has been on the net debt to EBITDA metric clearly. That is less of a focus now, but still want to understand the EBITDA guidance you gave for the year and the potential for operating leverage in the business over the next couple of years.
Yes. We have distribution business, which grows EBITDA in absolute terms, but brings down the combined overall percentages. Expect overall to grow as well because as we launch more in Crexont, more in other specialty assets, they are higher in margins. Complex GX as well as biosimilars, they are all higher in margins. It will go up and it will expand the margin. The investment we have made, we do not need to keep making it. Crexont marketing, we are spending $30 million more than Rytary in the first year, right? Then the revenue is outgrowing. Biosimilar, we set up a sales marketing commercial capabilities with $40 milllion-$45 million investment. It is incrementally now when we add products, it does not go up. A lot of operating expenses would be in line while revenue is growing up. Expect margin expansion significantly from now to next five years.
Fantastic. I think that'll be a good spot to leave this, Chirag. Thank you again for joining us.
Thanks a lot, Balaji.
I appreciate your product today.